Study of Gynecological Follow-up of Patients With Autoimmune Disease or Inflammatory Rheumatism

NCT05961267 | Completed

• 1 other identifier: CHUBX 2023/25
• Study Type: observational
• Target: 318
• Locations: 1 country
• Sites: 1

Brief Summary

Autoimmune diseases are the consequence of an abnormality of the immune system, leading it to attack components of our own body. They have a wide variety of presentations. They preferentially affect women, and often at a young age. Systemic lupus erythematosus, for example, most often occurs between the ages of 15 and 40. Inflammatory rheumatism, such as spondyloarthritis or rheumatoid arthritis, is less prevalent in women, but also affects young people, and is particularly common. Several disease-modifying treatments exist, depending on the severity and evolutivitý of the disease. Some are contraindicated or not recommended during pregnancy and therefore require supervision of pregnancy plans. In addition, some treatments have an immunosuppressive activitý, which implies an annual screening of cervical lesions by cervico-uterine smear. In this context, an adapted gynecological follow-up seems indispensable. The rheumatologist and the internist physician have a crucial role in advising and referring patients to their gynecological colleagues. Studying the qualitý of this gynecological follow-up in a cohort of patients with autoimmune disease or inflammatory rheumatism is of major interest.

Conditions

Arthritis, Rheumatoid; Spondylitis, Ankylosing; Lupus Erythematosus, Systemic; Scleroderma, Systemic; Sjogren's Syndrome; Mixed Connective Tissue Disease

Keywords

Auto-immune diseases; rare auto-immune diseases; contraception; gynecological follow-up

Outcome Measures

Primary Outcomes (1)

• Proportion of patients who report having a screening of cervical dysplasia during the year according to international recommendations.

  At baseline (Day 0)

Secondary Outcomes (7)

• Proportion of patients who report using effective contraception during the year.

  At baseline (Day 0)

• Proportion of patients who report that their auto-immune pathology had an impact on their pregnancy plans.

  At baseline (Day 0)

• Proportion of patients whose contraception does not comply with recommendations regarding their comorbidities.

  At baseline (Day 0)

• Prevalence of HPV infections in the study sample.

  At baseline (Day 0)

• Prevalence of cervical dysplasia in the study sample.

  At baseline (Day 0)

Study Arms (1)

Patients

Patients with a diagnosis of systemic lupus erythematosus, Gougerot-Sjögren's syndrome, scleroderma, Sharp's syndrome, rheumatoid arthritis or spondyloarthritis, according to current international standards.

Behavioral: Questionnaire

Interventions

Questionnaire BEHAVIORAL

A gynecological follow-up questionnaire will be proposed to patients with one of the above mentioned pathologies. This is a standardized questionnaire specifically designed for this study.

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient with a diagnosis of systemic lupus erythematosus, Gougerot-Sjögren's syndrome, scleroderma, Sharp's syndrome, rheumatoid arthritis or spondyloarthritis, according to current international standards.

You may qualify if:

• Female patient over 18 years of age
• Non-menopausal patient (only for the subgroup of patients used to assess the use of effective contraception)
• Patient with a diagnosis of systemic lupus erythematosus, Gougerot-Sjögren's syndrome, scleroderma, Sharp's syndrome, rheumatoid arthritis or spondyloarthritis, according to current international standards.
• French-speaking patient with no comprehension problems
• Person affiliated with or benefiting from a social securitý scheme
• Patient who received information about the protocol and gavé her consent

You may not qualify if:

• Pregnant or breastfeeding patient
• Patient with a history of total hysterectomy
• Patient referred to in articles L 1121-5 to L 1121-8 (persons deprived of liberty by a judicial or administrative decision, minors, adults subject to a legal protection measure or unable to express their consent).

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CHU de Bordeaux - service de rhumatologie

Bordeaux, France

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Spondylitis, Ankylosing; Lupus Erythematosus, Systemic; Scleroderma, Systemic; Sjogren's Syndrome; Mixed Connective Tissue Disease

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Ankylosis; Skin Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Christophe RICHEZ, Prof

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2023
• First Posted: July 27, 2023
• Study Start: July 24, 2023
• Primary Completion: June 28, 2024
• Study Completion: June 28, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)